Efficacy and Safety of Intragastric Balloon Therapy Compared to a Multidisciplinary Weight Loss Program (OPTIFAST) in a Real-World Population: A Propensity Score Matching Analysis.

INTRODUCTION: Obesity is a major global health problem associated with comorbidities such as diabetes, cardiovascular disease, and cancer. Bariatric surgery is recognized to be the most effective weight loss intervention, but it is highly invasive and costly and can have serious side effects. Intragastric balloon (IGB) placement by endoscopy and hypocaloric diets are among a number of techniques that have been used in patients unsuitable for, or unwilling to undergo, obesity surgery. In this study, we compared the efficacy, safety, and cost-effectiveness of the hypocaloric OPTIFAST program (OPT) with endoscopic IGB placement for weight loss. METHODS: In this retrospective observational cohort propensity score-weighted comparison (performed May 2014 to December 2020), participants with a BMI of 30-55 kg/m2, aged 18-70 years, were randomized to OPT or IGB for 26 weeks, followed by a weight maintenance phase. Patients were matched according to age, gender, and BMI. The study outcomes were percentage excess body weight lost, total body weight lost (TBWL), and percentage TBWL (%TBWL). RESULTS: A total of 148 participants (75% of those randomized; 74 OPT, 74 IGB) made up the ITT population. Mean age was 44.1 ± 10.4 years, and the patients were predominantly female (77%). Baseline BMI was 44.1 ± 10.4 kg/m2. At 26 weeks, %TBWL in the OPT group was 19.6 ± 6.8% versus 11.9 ± 6.7% for IGB (p < 0.001). At 52 weeks, %TBWL for OPT was 18.2 ± 9.0% versus 12.0 ± 6.6% for IGB (p < 0.001). The OPT cohort also experienced significantly fewer adverse events compared with the IGB group. CONCLUSION: IGB placement and OPT induce clinically meaningful weight loss. However, OPT appears to induce clinically superior weight loss and has economic advantages through lower rates of complications and adverse events.

Measuring Vitamin D Status in Chronic Inflammatory Disorders: How does Chronic Inflammation Affect the Reliability of Vitamin D Metabolites in Patients with IBD?

Evidence gained from recent studies has generated increasing interest in the role of vitamin D in extraskeletal functions such as inflammation and immunoregulation. Although vitamin D deficiency has been implicated in the pathophysiology of inflammatory diseases including inflammatory bowel disease (IBD), evidence as to whether vitamin D supplementation may cure or prevent chronic disease is inconsistent. Since 25OH-vitamin D (25OHD) has been suggested to be an acute-phase protein, its utility as a vitamin D status marker is therefore questionable. In this study, possible interactions of vitamin D and inflammation were studied in 188 patients with IBD, with high-sensitivity C-reactive protein (hsCRP) levels ≥ 5 mg/dL and/or fecal calprotectin ≥ 250 µg/g defined as biochemical evidence of inflammatory activity. Levels of 25OHD and vitamin D-binding protein (VDBP) were determined by ELISA, and 1,25-dihydroxyvitamin D (1,25OHD) and dihydroxycholecalciferol (24,25OHD) by LC-MS/MS. Free and bioavailable vitamin D levels were calculated with the validated formula of Bikle. Serum 1,25OH2D and vitamin D binding protein (VDBP) levels were shown to differ between the inflammatory and noninflammatory groups: patients with inflammatory disease activity had significantly higher serum concentrations of 1,25OH2D (35.0 (16.4-67.3) vs. 18.5 (1.2-51.0) pg/mL, p < 0.001) and VDBP (351.2 (252.2-530.6) vs. 330.8 (183.5-560.3) mg/dL, p < 0.05) than patients without active inflammation. Serum 24,25OH2D levels were negatively correlated with erythrocyte sedimentation rate (ESR) (-0.155, p = 0.049) while concentrations of serum 1,25OH2D correlated positively with hsCRP (0.157, p = 0.036). Correlations with serum VDBP levels were found for ESR (0.150, p = 0.049), transferrin (0.160, p = 0.037) and hsCRP (0.261, p < 0.001). Levels of serum free and bioavailable 25OHD showed a negative correlation with ESR (-0.165, p = 0.031, -0.205, p < 0.001, respectively) and hsCRP (-0.164, p = 0.032, -0.208, p < 0.001 respectively), and a moderate negative correlation with fecal calprotectin (-0.377, p = 0.028, -0.409, p < 0.016, respectively). Serum total 25OHD concentration was the only vitamin D parameter found to have no specific correlation with any of the inflammatory markers. According to these results, the traditional parameter, total 25OHD, still appears to be the best marker of vitamin D status in patients with inflammatory bowel disease regardless of the presence of inflammation.